Pharmaceutical forensics applies forensic expertise, analysis and problem solving principles to pinpoint when and where foreign particulate matter entered a manufacturing process, the root cause of product failures or the source of product stains or discoloration.

1. Gateway Analytical Pharmaceutical Forensic Services

2. Pharmaceutical Forensic Services © Gateway Analytical, LLC, 2011 - Non-Conformance Issues - OOS Investigations - Particle Contamination Characterization

3. Pharmaceutical Forensic Services - Foreign Particulate Matter Identification © Gateway Analytical, LLC, 2011 - Glass Defect Analysis - Product/Process Contamination Consultation

4. Foreign ParticulateWhat is it? Where did it come from? © Gateway Analytical, LLC, 2011 100 100 80 80 60 60 40 40 20 20 4000 3500 3000 2500 2000 1500 1000 4000 3500 3000 2500 2000 1500 1000 SEM / EDS Spectra Optical Image Infrared Spectra Absorbance Wavenumber cm-1 Silicone

5. Pharmaceutical Forensic Services © Gateway Analytical, LLC, 2011 - Product Return Analysis - Source Determination - 100% Particle Inspection - AutomatedParticleSizing and Identification

7. Microscopic analysis

8. Rinse studies on multiple vial lots

9. Foreign particulate studies on multiple vial lots

10. Sterile does not mean particle free!

11. Foreign particulate accounts for hundreds of 483’s each year

12. 100% Inspection Testing and Consulting Support

14. Mechanical or Thermal?

16. Why Choose Gateway Analytical? - Trusted quality system rooted in Quality by Design (QbD) principles © Gateway Analytical, LLC, 2011 - Proven history of excellent customer satisfaction - State-of-the-art analytical instrumentation and methods